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Trial registered on ANZCTR


Trial ID
ACTRN12613001048774
Ethics application status
Approved
Date submitted
7/06/2013
Date registered
19/09/2013
Date last updated
19/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of efficacy and safety of topical glyceryl trinitrate vs oral nifedipine in idiopathic perniosis: a randomized clinical trial
Scientific title
Comparison of efficacy and safety of topical glyceryl trinitrate vs oral nifedipine in idiopathic perniosis: a randomized clinical trial
Secondary ID [1] 282638 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perniosis (chilblains) 289339 0
Condition category
Condition code
Skin 289677 289677 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1= Topical glyceryl trinitrate cream 0.4%

To be applied twice daily, till complete resolution of lesions (approximately 1-8 weeks)
At weekly follow up visits, patients were examined by a consultant Dermatologist and improvement or deterioration of skin lesions was recorded on a per forma along with subjective assessment of improvement and any complaints about side effects.
Intervention code [1] 287305 0
Treatment: Drugs
Comparator / control treatment
Oral Nifedipine 10-40mg/day to be given according to severity of disease and area of involvement
For mild to moderate disease limited to only fingers or toes the starting dose was 10 mg once a day
For severe disease and mild to moderate disease involving both fingers and toes, starting dose was 10mg twice a day.
The dose was increased in increments of 10 mg at each follow up visit if the lesions were not responding, to a maximum of 40 mg/day in two divided doses till complete resolution of lesions (approximately 8 weeks)
At weekly follow up visits, patients were examined by a consultant Dermatologist and improvement or deterioration of skin lesions was recorded on a per forma along with subjective assessment of improvement and any complaints about side effects.
Control group
Active

Outcomes
Primary outcome [1] 289764 0
Therapeutic efficacy assessed clinically by a consultant dermatologist at weekly follow up visits and graded as mild, moderate or marked improvement in skin lesions.
Timepoint [1] 289764 0
Weekly follow up visits till complete clearance of skin lesions (approximately 8 weeks)
Secondary outcome [1] 303196 0
Safety. Subjective complaints of any side effects at follow up visits were noted.
Possible side effects for Oral Nifedipine include
Bloating or swelling of the face, arms, hands, lower legs, or feet
Cough
Difficult or labored breathing
Dizziness or light headedness
Palpitations
Headache
Muscle cramps
Rapid weight gain
Shortness of breath
Tightness in the chest
Tingling of the hands or feet
Weakness
Wheezing
Cyanosis
Chest congestion
Chest pain
Chills
Extreme fatigue
Fever
Increased sweating
Nausea
Vomiting
Pain or discomfort in the arms, jaw, back, or neck
Severe unusual tiredness or weakness
Sweating

Possible side effects of Topical GTN include
Local irritation
Erythema
Tingling sensation
Contact dermatitis
Head ache
Timepoint [1] 303196 0
Weekly follow up visits till complete clearance of skin lesions (approximately 8 weeks)

Eligibility
Key inclusion criteria
patients between 12 and 60 years of age
signs & symptoms typical of perniosis and
involvement of acral areas
Minimum age
12 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of any systemic disease
2. history of Raynaud’s phenomenon
3. patients currently taking any topical or systemic medication
4. pregnant or lactating female patients
5. blood pressure below 110/70 mm Hg
6. positive ANA or RA factor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with perniosis presenting at two tertiary care referral centers from 1st Dec 2012 to 31st Mar 2013 were screened and all eligible patients (according to inclusion and exclusion criteria), who gave written informed consent to participate in the trial were enrolled.
They were randomizd into either group A (topical GTN 0.4% cream) or group B (oral nifedipine, 10-40mg/day) by concealed random allocation (sealed envelopes).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence was determined by generating random tables using SPSS
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be analyzed using SPSS version 17. The therapeutic effects of two treatments will be compared using chi-square test with P value <.05 taken as significant
All patients presenting at two centers during the study period were enrolled

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5130 0
Pakistan
State/province [1] 5130 0
Punjab

Funding & Sponsors
Funding source category [1] 287416 0
University
Name [1] 287416 0
The University of Faisalabad

Address [1] 287416 0
4 Km, Sargodha Road, Faisalabad
Pakistan 38850
Country [1] 287416 0
Pakistan
Primary sponsor type
University
Name
The University of Faisalabad
Address
4 Km, Sargodha Road, Faisalabad
Pakistan 38850
Country
Pakistan
Secondary sponsor category [1] 286163 0
Hospital
Name [1] 286163 0
Madina Teaching Hospital
Address [1] 286163 0
University Medical and Dental College,Sargodha Road, Faisalabad
Country [1] 286163 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289392 0
Ethics committee on research- The University of Faisalabad
Ethics committee address [1] 289392 0
The University of Faisalabad
4-Km, Sargodha road, Faisalabad 38850
Ethics committee country [1] 289392 0
Pakistan
Date submitted for ethics approval [1] 289392 0
15/11/2012
Approval date [1] 289392 0
10/12/2012
Ethics approval number [1] 289392 0
TUF/BASR/03/101

Summary
Brief summary
It was a parallel group, single blinded, randomized clinical trial, in a multicenter study, carried out from December 2012 to March 2013, at Dermatology departments of two tertiary care referral centers i.e. Madina Teaching hospital and DHQ hospital, Faisalabad. All patients with perniosis were screened and all eligible patients (according to inclusion and exclusion criteria), who gave written informed consent to participate in the trial were enrolled.
They were randomizd into either group A (topical GTN 0.4% cream) or group B (oral nifedipine, 10-40mg/day) by concealed random allocation (sealed envelopes) according to the sequence generated by computerized random tables. They were evaluated for improvement in signs and symptoms and any side effects, weekly till complete recovery. Complete resolution of signs and symptoms was taken as the end point. Primary outcome was better efficacy and secondary outcome was side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40606 0
A/Prof Dr. Tanzeela Khalid
Address 40606 0
Madina Teaching Hospital
University Medical and Dental College
Sargodha Road, Faisalabad
Country 40606 0
Pakistan
Phone 40606 0
+92-41-8869891
Fax 40606 0
Email 40606 0
tanzeelakhalid@tuf.edu.pk
Contact person for public queries
Name 40607 0
A/Prof Dr. Tanzeela Khalid
Address 40607 0
Madina Teaching Hospital
University Medical and Dental College
Sargodha Road, Faisalabad
Country 40607 0
Pakistan
Phone 40607 0
+92-41-8869891
Fax 40607 0
Email 40607 0
tanzeelakhalid@tuf.edu.pk
Contact person for scientific queries
Name 40608 0
A/Prof Dr. Tanzeela Khalid
Address 40608 0
Madina Teaching Hospital
University Medical and Dental College
Sargodha Road, Faisalabad
Country 40608 0
Pakistan
Phone 40608 0
+92-41-8869891
Fax 40608 0
Email 40608 0
tanzeelakhalid@tuf.edu.pk